Surgical staple-clip and applier

ABSTRACT

A surgical staple-clip including a clip component and a securing member is used in a wide range of surgical procedures. The staple-clip may be introduced to a surgical site in an un-assembled condition through a small port or trocar. An applier for the staple-clip comprising a pair of opposed jaw-like channels is provided to position and apply the clip component and the securing member. The clip component is positioned around a target tissue and is compressed or clamped upon the tissue using only the force required for a specific surgical procedure such as occlusion, ligation or fixation. When the clip component is properly applied, the securing member is urged forward and over the clip component to secure the staple-clip. The clip component may include traction enhancement features such as surface interruptions, bumps, valleys and ridges. With the staple-clip of the invention, the force required to constrict or occlude the tissue is separate from the force required to secure and maintain the staple-clip in position and, as a result, the body tissue is not over-compressed and nourishment to the body tissue is maintained. Other aspects of the invention include thumb actuated clip appliers for use in hand assisted laparoscopy (HAL). In one embodiment, a clip applier includes a handle and a thumb actuated mechanism that is used to slidably release clips onto a body tissue or vessel by sliding the thumb actuated mechanism forward and backward using only one hand. In another aspect of the invention, a two-stage clip is disclosed having a clip component and a staple component for securing the clip after it has been properly positioned.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/200,582, filed on Aug. 28, 2008, currently pending, which is adivisional of U.S. patent application Ser. No. 10/533,398, filed on Apr.30, 2005, which is a 371 international application of PCT ApplicationNo. PCT/US03/040,318, filed on Dec. 16, 2003, which claims benefit ofU.S. Provisional Patent Application No. 60/434,344, filed on Dec. 17,2002, the disclosures of which are each hereby incorporated by referenceas if set forth in full herein.

BACKGROUND OF THE INVENTION

Field of the Invention

This invention generally relates to medical devices and, morespecifically, to a staple-clip and applier adapted for use in surgicalprocedures.

Discussion of the Prior Art

Clips and staples are widely used in many surgical procedures such asocclusion, ligation and fixation of various body tissues and vessels.Clips are generally U-shaped, open-ended wires that are positionedaround a target tissue and clamped together to constrict or occlude thetissue. A clip applier is typically used for applying the clips. Clipappliers can be configured for applying a single clip or multiple clipsin both open and minimally invasive or laparoscopic surgeries. Theindividual clips are provided in a loading cartridge or rack of a clipapplier. With minimally invasive surgery, a clip applier must be able todeliver clips through a small access port or trocar having a diameter ofabout 10 mm to 12 mm. Accordingly, the size of a deliverablelaparoscopic clip must be smaller than the inside diameter of the trocarthrough which it is introduced. Typically, a 12 mm clip applier iscapable of delivering a clip that is no longer than 7-8 mm. It is notuncommon for laparoscopic surgeons to discover that even the largestclip available is undersized for a particular surgical procedure.Moreover, clips will occasionally move about or slip off the tissue towhich they have been applied. In some cases, a surgeon may apply anexcessive compressive force to the clip and tissue to minimize movementor slippage of the clip. This excessive compression may cause necrosisof tissue since nutrition to the tissue is interrupted or eliminated.

Staples are also widely used in many surgical procedures to constrict orocclude a body tissue or vessel. A surgical staple typically includes apair of penetrating legs connected by a base portion. Surgical staplesare applied using a stapler, which compresses the penetrating legs asthe legs advance through the body tissue and are bent against anopposing jaw of the stapler to secure the staple to the body tissue. Afeature of the staple is it defines open portions that providenourishment to the tissue even when the staple is bent. Surgical stapleshave proved to be effective, however, the staplers used for applying thestaples are often bulky and require a very strong closing or compressingforce, which is not ideal for minimally invasive or laparoscopicsurgeries. As such, it is desirable to find a staple/clip providing goodtraction to prevent movement and slippage while requiring only a forceto close or compress the staple/clip. Specifically, it is desirable tohave a staple/clip where the force required to constrict or occlude abody tissue is separate from the force required to secure and maintainthe device in position. The staple-clip would provide good tractionwhile maintain proper nourishment to the body tissue. It is advantageousto use the staple/clip, for example, to secure the renal vessel in donornephrectomy.

SUMMARY OF THE INVENTION

The present invention is directed to a surgical staple-clip for use in awide range of surgical procedures. The staple-clip comprises a pluralityof individual elements including a clip component and a securing orfixation member connected with the clip component to form a compositestaple-clip. The composite staple-clip may be configured for use in bothopen and minimally invasive or laparoscopic surgeries. The staple-clipmay be introduced to a surgical site in an un-assembled conditionthrough a small port or trocar. An applier for the staple-clipcomprising a pair of opposed jaw-like channels is provided to positionand apply the clip component and the securing member. The clip componentis positioned around a target tissue and is compressed or clamped uponthe tissue using only the force required for a specific surgicalprocedure such as occlusion, ligation or fixation. When the clipcomponent is properly applied and the desired effects are observed, thesecuring member is urged forward and over the clip component to securethe staple-clip.

In one aspect of the invention, the clip component includes tractionenhancement features including surface interruptions, bumps, valleys,ridges and the like. In another aspect of the invention, the clipcomponent includes tissue-penetrating features similar to those of astaple. It is appreciated that with the staple-clip of the invention,the force required to constrict or occlude the tissue is separate fromthe force required to secure and maintain the staple-clip in position.That is, only the compressive force needed to perform a specificsurgical procedure such as occlusion, ligation or fixation is applied tothe body tissue, and the force normally required to secure and maintaina clip of the prior art is not applied since traction and security aresupplied by the clip component and securing member of the staple-clip.As a result, the body tissue is not over-compressed and nourishment tothe body tissue is maintained.

Other aspects of the invention include thumb actuated clip appliers foruse in hand assisted laparoscopy (HAL). In one embodiment, a clipapplier includes a handle and a thumb actuated mechanism that is used toslidably release clips onto a body tissue or vessel by sliding the thumbactuated mechanism forward and backward using only one hand. This designcloses the jaws around the body tissue or vessel and allows a closedclip to slide into position. In another embodiment, a clip is providedhaving a first arm and a second arm folded over the first arm. The firstarm includes a latch mechanism such as an inwardly turned portion orhook at its distal end that is configured to interlock or mate with adistal end of the second arm when the arms are clamped together. Thelatch mechanism operates in a similar way to a hair clip and responds tothumb pressure. An operator may single-handedly access the clip andslide it onto a body tissue or vessel as needed. The arms of the clipmay include tissue-penetrating elements on the inner, opposed faces ofthe arms.

In another aspect of the invention, a two-stage clip is disclosed havinga clip component and a staple component for securing the clip after ithas been properly positioned. The clip component is formed from a firstpiece of material and includes opposed arms, each of which includesopenings allowing penetration of legs of the staple component. Thestaple component is formed from a second piece of material and is usedto puncture a body tissue or vessel and to interlock the clip component.The arms of the clip component may include a latch mechanism at thedistal ends to mate with each other when the arms are closed or clampedtogether. During use, the first stage closes the arms of the clip. Afterthe first stage, the clip can still be safely removed. The second stagesecures the clip permanently onto the body tissue or vessel by applyingthe staple component to the clip component. In another embodiment, atwo-stage clip is formed entirely from a single piece of material andincludes a first arm and an opposed second arm. The second arm furtherincludes securing elements, all of which are formed as an integral,one-piece construction. With this construction, the securing elementsmay still remain open after the first stage when the arms are clampedupon a body tissue or vessel. A second action then presses the securingelements into the body tissue or vessel.

These and other features and advantages of the invention will becomemore apparent with a discussion of preferred embodiments in reference tothe associated drawings.

DESCRIPTION OF THE DRAWINGS

FIGS. 1(a) and 1(b) illustrate a typical surgical clip in an opencondition and a closed condition, respectively;

FIG. 2 illustrates the movement and slippage of a typical surgical clip;

FIGS. 3(a) and 3(b) illustrate a typical surgical staple in an opencondition and a closed condition, respectively;

FIGS. 4(a) and 4(b) illustrate a typical arrangement of open and closedsurgical staples, respectively;

FIGS. 5(a) and 5(b) illustrate a typical surgical clip applier andstaple applier, respectively;

FIG. 6(a) is a perspective view of the clip components and securingmember of the staple-clip in accordance with an embodiment of theinvention;

FIG. 6(b) is a perspective view of the assembled staple-clip of FIG.6(a);

FIG. 7 is a perspective view of the assembled staple-clip of FIG. 6(b)placed upon a body conduit or passage;

FIG. 8 is a perspective view of the staple-clip and applier configuredfor use in a minimally invasive surgical procedure;

FIGS. 9(a), 9(c), 9(e) and 9(g) are side views of the staple-clip of theinvention in an open, closing, closed and locked condition,respectively;

FIGS. 9(b), 9(d), 9(f) and 9(h) are end views of the staple-clip ofFIGS. 9(a), 9(c), 9(e) and 9(g), respectively;

FIGS. 10(a) and 10(b) are perspective views of a clip in an open andclosed condition, respectively, having a monolithic construction inaccordance with another embodiment of the invention;

FIGS. 10(c) and 10(d) are side views of the clip of FIGS. 10(a) and10(b), respectively, having pointed tissue-penetrating elements;

FIGS. 10(e) and 10(f) are end views of the clip of FIGS. 10(c) and10(d), respectively;

FIGS. 11(a) and 11(b) are side views of the staple-clip before and afterplacement upon a body conduit or passage, respectively;

FIGS. 11(c) and 11(d) are end views of the staple-clip of FIGS. 11(a)and 11(b), respectively;

FIGS. 12(a) and 12(b) are schematic side views of a staple-clip applierin a closed and open condition, respectively;

FIGS. 12(c) and 12(d) are front, end views of the staple-clip applier ofFIGS. 12(a) and 12(b), respectively;

FIGS. 13(a) and 13(b) are perspective views of the tissue contactingface portions of a staple-clip in another aspect of the invention;

FIG. 14 illustrates the sequence of placing the securing member upon thetissue-engaging members of the staple-clip of the invention;

FIGS. 15(a), 15(b) and 15(c) illustrate the invention sized andconfigured to pass through a small trocar port in a first condition,second condition and final condition, respectively;

FIG. 16 illustrates placement of a single staple-clip of the invention;

FIG. 17 illustrates parallel placement of the staple-clips of theinvention;

FIG. 18 illustrates parallel placement of the staple-clips of theinvention with a cutting element placed between the staple-clips;

FIG. 19 illustrates a laparoscopic stapler configured for use in donornephrectomy in accordance with another aspect of the invention;

FIGS. 20(a)-20(e) illustrate various thumb actuated clip appliers foruse in hand assisted laparoscopy (HAL) in accordance with additionalaspects of the invention;

FIG. 21 illustrates a spring like coil for suturing a body tissue orvessel in accordance with another aspect of the invention;

FIG. 22 illustrates a plurality of staples formed from a single piece ofmaterial in accordance with another aspect of the invention;

FIG. 23 illustrates a temporary HAL clamp for use in donor nephrectomyin accordance with another aspect of the invention;

FIGS. 24-26 illustrate various two-stage staple-clips in accordance withadditional aspects of the invention; and

FIG. 27 illustrates a holder to press a body tissue flat and to provideclearance during placement of a staple-clip having sharp features.

DESCRIPTION OF PREFERRED EMBODIMENTS AND BEST MODE OF THE INVENTION

FIGS. 1 and 2 illustrate a surgical clip 10 of the prior art having agenerally open shape including a first leg 15, a second leg 20 and abase 30 connecting the first leg 15 and the second leg 20. The clip 10can be positioned around a body conduit or passage, e.g., a bloodvessel, and compressed using a clip applier 150 as illustrated in FIG.5(a). The clip applier 150 generally comprises an elongate shaft 155,sized and configured to fit through a surgical trocar port, a distal end160 having a pair of opposed jaws 165, 167 and a proximal end 170 havinga handle 180 to open and close the jaws 165, 167. The clip 10, held inan open condition, is supplied to the jaws 165, 167 either automaticallyor manually. The clip 10 is advanced to a desired site and subsequentlyclosed or compressed. With the first and second legs 15 and 20 properlyformed, the jaws 165, 167 can be opened and moved away from the tissueleaving the clip 10 clamped around the tissue. The clip 10 derives itsstrength from the material from which it is made. The material chosenmust be sufficiently malleable to allow the clip to be compressed asillustrated in FIG. 1(b) while preventing spring-back of the materialafter application of a compressive force.

There are many factors that must be considered in applying a surgicalclip to a body tissue or vessel. First, the clip must be sufficientlywide to completely encompass the tissue. As illustrated in FIG. 1(a),the clip 10 must have an open area 50 that is wide enough to encompassthe target tissue. Second, the clip must be compressible with areasonable application force, i.e., a force that an operator feelscomfortable applying to the body tissue. Third, the clip, once applied,must not move from the location where it was applied. As illustrated inFIG. 2, the clip 10 must not slip along axes 80(a) or 80(b) or slip offof body vessel 60. A fourth factor is that the clip 10 should notcompress the body tissue so much that it constricts, interrupts ordestroys the nourishment of the tissue. As can be seen, the abovefactors of clip-based ligation or fixation are difficult to achieveusing a single wire-formed clip. Moreover, the issues of compression andtraction must be separated if proper nourishment of the tissue is to bepreserved while maintaining a secure placement of the clip.

Surgical staples are another device that is commonly used for occlusion,ligation and fixation of body tissues and vessels. Referring to FIG.3(a), a typical surgical staple 100 comprises generally straight,penetrating leg portions 110 and 120 connected together by a baseportion 130. As the penetrating leg portions 110, 120 are applied to abody tissue or vessel, the leg portions advance through the tissue andare bent against the opposing jaw of the stapler and toward each otheras illustrated in FIG. 3(b). The bending of the staple 100 forms aconfinement of the body tissue that is, for the most part, independentof the compression of the tissue itself. FIG. 5(b) illustrates alaparoscopic stapler 190 that operates in much the same way as a clipapplier. During use, the stapler 190 is advanced over a portion of bodytissue and is compressed to deliver at least one, and more oftenseveral, penetrating surgical staples. See, for example, FIGS. 4(a) and4(b). The compressed surgical staple 100 has a general shape of thecapital letter “B” where fluid nourishment of the tissue is providedthrough open portions 140 of the folded staple 100. Surgical stapleshave proved to be effective and are a standard in surgery. However, thestaplers used for applying the staples are often bulky and require avery strong closing or compressing force, which is not ideal forminimally invasive or laparoscopic surgeries. Accordingly, there is aneed in the art for a device having features and advantages of both thestaple and clip. The staple/clip would provide good traction to preventthe device from moving or dislodging from the body tissue whilemaintaining proper nourishment to the tissue. In addition, the forcerequired to constrict or occlude the body tissue would be separated fromthe force required to secure and maintain the device in position.Specifically, the portion of tissue to be treated would not becompressed more than is necessary to achieve the desired result.

FIG. 6(a) illustrates a surgical staple-clip 200 in accordance with afirst embodiment of the invention. The staple-clip 200 comprises a firsttissue-engaging member 205, a second tissue-engaging member 210 opposedto the first tissue-engaging member 205, and a securing or fixationmember 220 for securing the first and second tissue-engaging members205, 210. The first tissue-engaging member 205 comprises generallyopposed walls 230, 232 and a connecting wall 234 that together define anelongate channel 236. The second tissue-engaging member 210 is similarto the first tissue-engaging member 205 and comprises generally opposedwalls 240, 242 and a connecting wall 244 that together define anelongate channel 246. The tissue-engaging members 205, 210 are normallyheld such that the front faces of the connecting walls 234, 244,respectively, are opposed to each other. The opposing front faces of theconnecting walls 234, 244 may include a plurality of tissue-penetratingelements 238, 248, respectively.

An advantage of the staple-clip of the invention is it provides goodtraction without requiring an excessive compressive force to be appliedto the staple-clip. In particular, the securing member 220 is sized andconfigured to slide into the elongate channels 236, 246 to securelyclamp the tissue-engaging members 205, 210 around a body tissue orvessel with minimal compressive force. More specifically, the forcerequired to secure and maintain the staple-clip (to provide adequatetraction) is independent from the force required to constrict or occludea body tissue or vessel. With the staple-clip of the invention, only thecompressive force needed to perform a specific surgical procedure suchas occlusion, ligation or fixation is applied to the body tissue, andthe force normally required to secure and maintain a clip of the priorart is not applied since traction and security are supplied by thetissue-engaging members 205, 210. In other words, the staple-clip of thepresent invention provides the necessary traction without requiring anexcessive compressive force to keep the staple-clip from moving orbecoming loose. As a result, nourishment of the lightly compressedtissue is maintained and tissue necrosis due to over-compression iseliminated.

In another aspect of the invention, the tissue-engaging members includetraction enhancing features including bumps, ridges, slots, holes, etc.as generally illustrated in FIGS. 13(a) and 13(b). The tractionenhancing features are sized and configured to grip tissue and providetraction and security beyond that which might be achieved byover-compressing a typical clip. The securing member 220 may be aspring-clip or a deformable clip acting as a retention member andproviding a uniform pressure across the occluded tissue or vessel toprevent loosening of the staple-clip 200 over time as illustrated inFIGS. 7, 9(a)-9(h) and 14. The tissue-penetrating elements 238, 248 areconfigured to penetrate the tissue and to prevent the tissue from movingor sliding when clamped as illustrated in FIGS. 11(a)-11(d), 16 and 17.

It is appreciated that the connecting walls 234, 244 and the respectivetissue-penetrating elements 238, 248 may be formed as an integral,one-piece construction. It is further appreciated that the number ofrows of tissue-penetrating elements and the number of tissue-penetratingelements per row may vary according to each application and the shapeand size of the clip and body tissue. It is further noted that thetissue-penetrating elements in each row may be aligned or staggered asdesired. The tissue-engaging members 205,210 and the securing member 220may have cross-sections of any configuration including polygonal,circular and elliptical configurations.

Referring to FIG. 10, there is shown a monolithic staple-clip 500 inaccordance with another aspect of the invention. The monolithicstaple-clip 500 has a general shape of the capital letter “U”. Thestaple-clip 500 comprises a first tissue-engaging portion or leg 505, anopposed second tissue-engaging portion or leg 510 and a deformableconnecting portion 520 connecting the first and second tissue-engagingportions 505 and 510. Each of the opposing faces of the tissue-engagingportions 505, 510 comprises a plurality of tissue penetrating elementsor protrusions 525, 530, respectively. The protrusions are sized andconfigured to penetrate tissue that is captured between thetissue-engaging portions and provide traction and security beyond thatwhich might be achieved by over-compressing a typical clip. Similar toother aspects of the invention, only the force required to perform aspecific surgical procedure such as occlusion, ligation or fixation isapplied to a body tissue and the force previously needed to secure andmaintain the clip is no longer applied. Nourishment of the lightlycompressed tissue is thus maintained and tissue necrosis due toover-compression is eliminated.

The monolithic staple-clip 500 may be formed from a flat metal sheetthat is die-cut, stamped or etched forming a first notched or toothedportion, a smooth connecting portion and a second notched or toothedportion. The notches or teeth of the first and second portions are thenbent so as to extend in the same direction or plane and to form channelswithin the notches or teeth. The staple-clip is then formed in a U-shapeby bending the connecting portion so that the notches or teeth of thetwo tissue-engaging portions are opposed. A preferred embodiment of themonolithic staple-clip comprises a malleable material such as Titaniumor stainless steel. Other materials include any medically acceptablemetal or plastic material that is ductile, malleable or deformable.

It is appreciated that the staple-clips of the invention can be appliedto a body tissue or vessel using an applier 600 as illustrated in FIGS.12(a)-12(d). The staple-clip applier 600 generally comprises an elongateshaft 605, sized and configured to fit through a surgical trocar port, adistal end 610 having a pair of opposed jaws 615, 620, and a proximalend (not shown) having a handle to open and close the jaws 615, 620. Thestaple-clip applier 600 further comprises a sliding member 625 toadvance the securing member 220 over the tissue-engaging members 205,210 after closure of the jaws 615, 620 as further described below. Thejaws 615, 620 operate to apply the tissue-engaging members 205, 210,respectively, around a target body tissue or vessel. The tissue-engagingmembers are supplied to the jaws either manually or automatically. Withthe tissue-engaging members 205, 210 properly placed, the jaws 615, 620can be compressed using only the force required for a specific surgicalprocedure such as occlusion, ligation or fixation. When thetissue-engaging members 205, 210 are properly applied, the slidingmember 625 can then urge the securing member 220 forward and over thetissue-engaging members 205, 210 to secure the staple-clip 200 asillustrated in FIGS. 9(a)-9(h), 11(a)-11(d) and 14. The tissue-engagingmembers 205, 210 and securing member 220 may be introduced to a surgicalsite in an un-assembled condition through a small port or trocar. FIGS.8 and 15(a)-15(c) further illustrate the staple-clip and applier sizedand configured for use in a minimally invasive or laparoscopic surgicalprocedure.

Multiple staple-clips may also be loaded in a staple-clip applier andadvanced individually or simultaneously between the jaws. In the case ofsimultaneously applying the staple-clips, the applier must include aplurality of slots in the opposed jaws to receive the multiplestaple-clips. A cutting member such as a blade may be included in theapplier to be advanced between the staple-clips after they have beenapplied to transect the body tissue between the staple-clips asillustrated in FIGS. 17 and 18.

In another aspect of the invention, FIG. 19 depicts a traditionallaparoscopic stapler 800 that is configured specifically for donornephrectomy. The stapler 800 includes a plurality of rows of staples onthe patient side 805 and a temporary clip 810 that substitutes for atypical set of staples on the kidney side 815. The stapler 800 operateslike existing place and cut staplers with the exception that a temporaryclip or clips 810 replace the set of staples on the kidney side 815. Thetemporary clip 810 may be a staple cartridge configured for use in donornephrectomy. An advantage of this configuration is it salvages a greaterportion of the vessel for the transplant procedure.

Another aspect of the invention is directed to hand assisted laparoscopy(HAL), the widespread acceptance of which has created many opportunitiesfor surgical advancement utilizing single hand procedures. FIGS.20(a)-20(e) illustrate thumb actuated clip appliers 850, 875 and 895 inaccordance with the teachings of the invention. The clip applier 850includes a handle 855 and a thumb actuated mechanism 860. An operatorcan slidably release clips 865 onto a vessel by sliding the thumbactuated mechanism 860 forward 870 a and backward 870 b using only onehand as illustrated in FIGS. 20(a)-20(b). This design closes the jawsaround the vessel and allows a closed clip to slide into position. Thehandle 855 also serves as a reservoir for additional clips 865. The clip875 is also designed for HAL applications and includes a first arm 880and a second arm 885 folded over the first arm 880. The first arm 880includes a latch mechanism 890 such as an inwardly turned portion orhook at its distal end that is configured to interlock or mate with adistal end of the second arm 885 when the arms are clamped together. Thelatch mechanism 890 operates in a similar way to a hair clip andresponds to thumb pressure. An operator may single-handedly access theclip 875 and slide it onto a body tissue or vessel as needed.

A plurality of clips 875 may be strung end-to-end in a clip sleeve 892suspended through an open port. An advantage of the clip 875 is there isno instrument to misplace. The clip sleeve 892 holding the clips 875 canalso be withdrawn or fed through any open port or trocar. The clipsleeve 892 can also be designed to keep the clips 875 partially closed,enabling the use of smaller ports or trocars. The clip 895 asillustrated in FIG. 20(e) is similar to the clip 875 but furtherincludes tissue-penetrating elements 898 on the inner faces of arms 896,897. The clip 895 may also include a third arm 899 connecting the arms896, 897.

In another aspect of the invention as illustrated in FIG. 21, a springlike coil 900 is used for suturing a body tissue or vessel in place ofclips and staples. The spring like coil 900 is applied onto a bodytissue or vessel 905 by using a stapler 910 having grooved jaws 910,915. The spring like coil 900 is preferably loaded or twisted into oneof the grooved jaws 910, 915, which is then compressed or clampedagainst the other grooved jaw to constrict or occlude the vessel 905. Anadvantage of this design is closure of the coil 900 provides a stitchlike nature that replicates a uniformly applied suture. In oneconfiguration, a single coil is inserted in place of each suture. It isappreciated that a single coil or multiple coils may be loaded into thegrooved jaws of a stapler for each specific surgical procedure orclosure.

In yet another aspect of the invention, FIG. 22 illustrates multiplestaples 925 formed from a single piece of material 930 to reduce thehigh manufacturing costs associated with current stapler cartridges.These costs savings translate to increased margins or reduced productcost. Each of the staples 925 has an angled leg 935 and an inclined rail940 for easy push up and closure by a stapler. The staples 925 all sharea common portion 945, which allows the row of staples to be formed as anintegral, one-piece construction. The staples 925 can also be formed tooffset each other and to emulate multiple rows. An advantage of thisaspect of the invention is it provides a compact cartridge that issuitable for donor nephrectomy.

FIG. 23 illustrates a temporary HAL clamp 950 for use in donornephrectomy in accordance with another aspect of the invention. Theclamp 950 includes a tubular section 955 defining an opening 960extending from a proximal end 965 to a distal end 970, and a lead-inwire 975 operably attached to the proximal end 965. The lead-in wire 975is movable between an open position and a closed position. When closed,the lead-in wire 975 is slidably received and secured in the opening 960of the tubular section 955. During use, an operator may manually wrap avessel or vessels (e.g., the renal artery and vein can be cinchedtogether into the clamp) around the lead-in wire 975 and secure the wire975 in the opening 960 of the tubular section 955. The lead-in wire 975may be bent against the wall of the tubular section 955 to furthersecure the vessel(s) for kidney removal and transport.

FIGS. 24, 25 and 26 illustrate two-stage clips 1010, 1020 and 1030,respectively, in accordance with additional embodiments of theinvention. The clips 1010, 1020 and 1030 require an applier (not shown)for placement onto a body tissue or vessel. The clip 1010 includes aclip component 1011 and a staple 1012 for securing the clip after it hasbeen properly positioned. The clip component 1011 is formed from asingle wire and includes opposed arms 1013, 1014. Each of the arms 1013,1014 includes openings 1015, 1016, respectively, allowing penetration oflegs 1017, 1018 of the staple 1012. The staple 1012 is formed from asecond wire and is used to puncture the body tissue or vessel andinterlock the clip component 1011. The arms 1013, 1014 may include alatch mechanism at the distal ends to mate with each other when the armsare closed or clamped together. During use, the first stage closes thearms 1013, 1014 of the clip. After the first stage, the clip can stillbe safely removed. The second stage secures the clip permanently ontothe body tissue or vessel by applying the staple 1012 to the clipcomponent 1011.

The two-stage clip 1020 as shown in FIG. 25 is formed entirely from asingle piece of material and includes a first arm 1021 and an opposedsecond arm 1022. The second arm 1022 further includes securing elements1023, 1024, all of which are formed as an integral, one-piececonstruction. With this construction, the securing elements 1023, 1024may still remain at an angle after the first stage (when the arms 1021and 1022 are clamped upon a body tissue or vessel). A second action thenpresses the securing elements 1023, 1024 into the body tissue or vessel.The clip 1030 as shown in FIG. 26 is similar to the clip 1010 andincludes a clip component 1031 and a staple component 1032 for securingthe clip after it has been properly positioned. The clip component 1031includes opposed arms 1013, 1014 defining openings 1035, 1036,respectively. The staple component 1032 includes opposed arms 1037, 1038having tissue-securing elements 1039, 1040, respectively, which operateto secure the clip onto a body tissue or vessel through the openings1035, 1036. The clip 1030 may be formed in sheet stock.

FIG. 27 illustrates a tissue holder 1100 for use with staple-clips thatmay include sharp features, e.g., tissue-penetrating elements, that canpotentially injure tissue during a surgical procedure. In particular,the tissue holder 1100 is used to press a body tissue flat and toprovide clearance during placement of a staple-clip.

Although exemplary embodiments of the invention have been shown anddescribed, many alterations and modifications may be made by thosehaving ordinary skill in the art without departing from the spirit andscope of the invention. Therefore, it must be understood that theillustrated embodiments have been set forth only for the purposes ofexamples and that they should not be taken as limiting the invention. Inaddition, the words used in this specification to describe the inventionand its various embodiments are to be understood not only in the senseof their commonly defined meanings, but to include any specialdefinition given in this specification.

The invention claimed is:
 1. An applier for applying a medical device toconstrict or occlude a body tissue or vessel, the applier comprising: atleast one staple-clip comprising: a first tissue-engaging member havingopposed walls and a first connecting wall defining a first elongatechannel; a second tissue-engaging member opposed to the firsttissue-engaging member having opposed walls and a second connecting walldefining a second elongate channel; and a securing member for securingthe first and the second tissue-engaging members such that front facesof the first and the second connecting walls are opposed to each other;an elongate shaft having a proximal end and a distal end; a pair ofopposed jaws connected at the distal end of the elongate shaft; a handleoperably connected at the proximal end of the elongate shaft to open andclose the opposed jaws; and a sliding member operably connected withinthe elongate shaft to advance the securing member over the first and thesecond tissue-engaging members such that the securing member is slidlongitudinally with respect to the first elongate channel and the secondelongate channel within the first elongate channel and the secondelongate channel after closure of the jaws, the sliding member operableindependently of the opposed jaws.
 2. The applier of claim 1, whereinthe jaws operate to apply the first and the second tissue-engagingmembers around a target body tissue or vessel.
 3. The applier of claim2, wherein the first and the second tissue-engaging members are appliedto the jaws either manually or automatically.
 4. The applier of claim 2,wherein the first and the second tissue-engaging members and thesecuring member are introduced to a surgical site in an un-assembledcondition through a small port or trocar.
 5. The applier of claim 1,wherein the applier and the medical device are sized and configured foruse in a minimally invasive or laparoscopic surgical procedure.
 6. Theapplier of claim 1, further comprising a plurality of slots in each ofthe opposed jaws to receive a plurality of staple-clips tosimultaneously apply the plurality of staple-clips.
 7. The applier ofclaim 6, further comprising a cutting member to be advanced betweenstaple-clips after they have been applied to transect the body tissue orvessel between the staple-clips.
 8. The applier of claim 1, wherein theelongate shaft is sized and configured to fit through a surgical trocarport.
 9. The applier of claim 1, wherein the first tissue-engagingmember comprises tissue penetrating elements protruding therefrom. 10.The applier of claim 1, wherein the securing member comprises a springclip configured to provide uniform pressure along the first elongatechannel and the second elongate channel.